Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
Not Applicable
Completed
- Conditions
- Pancreatic Neoplasms
- Interventions
- Radiation: stereotactic radiotherapy
- Registration Number
- NCT02292745
- Lead Sponsor
- Foundation for Liver Research
- Brief Summary
The purpose of this study is to investigate whether combining FOLFIRINOX chemotherapy and stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an increase in survival.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Inclusion Criteria
- Cytological or histologically confirmation of pancreatic cancer.
- WHO performance status of 0 or 1
- ASA classification I or II
- Tumor considered locally advanced after diagnostic work-up including CT-imaging and diagnostic laparoscopy.
- No evidence of metastatic disease
- Largest tumor diameter < 7 cm x 7 cm x 7 cm
- Normal renal function (Creatinine ≥ 30 ml/min).
- Normal liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times normal)
- Normal bone marrow function (WBC > 3.0 x 10e9/L, platelets > 100 x 10e9/L and hemoglobin > 5.6 mmol/l)
- Age > 18 years and < 75 years
- Written informed consent
Exclusion Criteria
- Prior radiotherapy, chemotherapy or resection (bypass surgery allowed).
- Lymph node metastases from primary tumor outside the field of radiation.
- Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence.
- Pregnancy, breast feeding.
- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stereotactic radiotherapy stereotactic radiotherapy Standard of care FOLFIRINOX treatment followed by stereotactic radiotherapy
- Primary Outcome Measures
Name Time Method overall survival up to 3.5 years after start of therapy
- Secondary Outcome Measures
Name Time Method time to development of distant metastases up to 3.5 years after start of therapy number of toxicity events related to chemotherapy up to 3.5 years after start of therapy radiological response rates after chemotherapy and radiotherapy up to 3.5 years after start of therapy time to locoregional disease progression up to 3.5 years after start of therapy predictive value of a set of biological markers for treatment response up to 3.5 years after start of therapy number of resections at end of stereotactic radiotherapy up to 3.5 years after start of therapy
Trial Locations
- Locations (1)
Erasmus MC
🇳🇱Rotterdam, Netherlands